Publicity of drug registration application to be included in the priority review procedure of CDE
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Last Update: 2016-04-28
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Source: Internet
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Author: User
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According to the announcement of opinions on solving the backlog of drug registration applications and implementing the priority review and approval by the General Administration, the center organized experts to review and demonstrate the drug registration applications applying for the priority review procedure in accordance with the priority review work procedure of the drug review center (Trial) Now, the drug varieties to be prioritized for evaluation and the applicant are publicized for 5 days If there is any objection during the publicity period, please fill in the appendix "objection form of drug registration application priority review and approval varieties" as required, and feed back to our center: wuq@cde.org.cn No drug name patent expiration time acceptance No enterprise name center acceptance time Note 1 patent of gefitinib compound cn96193526 X expires on April 23, 2016 cxhs1400008 Qilu Antai (Linyi) Pharmaceutical Co., Ltd; Qilu Pharmaceutical Co., Ltd is the first domestic product to be reported on January 26, 2014 The patent of gefitinib Tablet Compound cn96193526 X expires on April 23, 2016 Cyhs1490010 Qilu Pharmaceutical (Hainan) Co., Ltd January 28, 2014 Drug evaluation center of State Food and Drug Administration Appendix 1 of April 28, 2016: Drug registration application priority review approval variety objection form.doc
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